Senior Group Director, Technical Regulatory Affairs

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The people leader leads a team of China Technical Partners (CTPs) and CMC professionals that are accountable for China regulatory CMC submissions, through developing and implementing robust end-to-end China filing strategies based on close collaboration with global development teams, China business priorities, China regulatory requirements and landscape. The scope includes the complete Roche portfolio, the global products (small molecules, biologics, new modalities). The focus of this role is to lead and coach the team members in order to accelerate drug access and continuous supply to the patients by ensuring right first-time submissions to Chinese Health Authorities and effective interactions with the Health Authority. The incumbent of the role is responsible to shape the regulatory environment in China in close collaboration with PTR Policy and translate that into innovative regulatory strategies. In line with Roche’s China strategy and the China First initiative, this is a role with a high business impact.

In this position, the people leader is responsible for the management of China Technical Partners (CTPs) and CMC program managers, which includes setting performance objectives, providing timely feedback, and ensuring alignment of short-term development goals with longer-term career goals. Provides guidance and manages work activities of others for specific projects and/or objectives. Demonstrates the fundamentals of effective coaching skills and mentoring. Adapts coaching style to meet the needs of the individual.

The people leader leads cross-functional regulatory initiatives and strategies, defines associated critical steps and resources needed and takes responsibility for implementation of these initiatives and strategies. Proactively communicates with regulatory and cross-functional personnel in support of internal and partner-associated project goals. Collaborates with management in leading communications with HA on projects and initiatives of major complexity. Makes decisions based on cross-functional priorities rather than functional area priorities.

Project People Leader

Provide leadership to a team of regulatory professionals.

Responsible for performance management of employees.

Work with direct reports and ensure that objective and timely feedback is provided to employees, focus on the development of the employee by facilitating regular development discussions and check-ins.

Provide coaching and mentoring to colleagues for an assigned area of technical regulatory responsibility.

Work closely with the Portfolio Leader to coordinate resources and priorities at a Portfolio level.

Regularly follow up and check in the progress of every specific project in the team, enlighten the team to work out submission strategies for different applications and identify regulatory risks and develop migration plans.

Build and maintain a healthy relationships with internal & external  key stakeholders, like NMPA, CDE, NIFDC, Supply Chain, Quality and compliance, PDR China and PTR global,

Collaborate with internal key stakeholders  for development and alignment of technical strategy, maximizing and balancing regulatory and supply needs in China.

QUALIFICATIONS

Education

Master’s Degree in life science disciplines is preferred; Post Graduate Degree is a plus.

Experience

8 or more years work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory or related experience.

Previous People management or cross-functional team leadership experience is desired.

Knowledge/Skills/Competencies

Regulatory Strategy and Operational Knowledge / Business Acumen

Proven knowledge of China Health Authority guidelines and experience in interacting

with health authorities.

Proven track record to develop regulatory strategies and scenario planning with robust regulatory risk assessment.

Technical understanding of drug substance and product manufacturing, in one or both modalities

SM and LM and product development processes, as appropriate.

Knowledge of drug development, commercialization process, supply chain complexity and

Pharmaceutical Quality Systems and knowledge of multidisciplinary functions involved in drug development (all functions), manufacturing, commercialization and product lifecycle management.

Operate with an agile mindset and drive for continuous improvement.

Collaborations and Leadership

Able to build and maintain productive and trusted relationships within/across departments as well as with external partnerships and regulators, between companies and cultures.

Proven track record of team leadership, preferably cross-functional teams.

Ability to develop people through coaching

Outstanding organizational and time management skills; proven ability to work under pressure.

Exceptional influencing and negotiation skills: extracts optimized business results through skillful collaboration with others (at all levels and across organizations) without formal authority and is highly adept at identifying solutions that will balance the needs of all parties involved.

Excellent interpersonal and collaboration skills: proven track record of building strong and sustainable relationships with internal and external partners/stakeholders.

Demonstrates, or has proven abilities to demonstrate Roche Values and Leadership Competencies.

Communication

Excellent communication and presentation skills: exhibits professional maturity, confidence and competence.

Able to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making.

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.